That being said, from a business perspective, I'm not satisfied with generating $14.3 million in revenue this quarter. These readouts will be two important data catalysts for the company, and we believe the newly generated information should support continued long-term growth of Vafseo prescribing. In the long run, I believe this change, enabling observed dosing, will improve physicians' ability to drive patient adherence and compliance, which have been factors impacting growth. We believe this reflects that physicians are getting comfortable treating patients to the optimal therapeutic dose and that this trend of increasing average dose will have a positive impact on revenue.

In summary, overall, Vafseo demand in quarter three was flat versus quarter two, with new patient starts offset by lower-than-expected initial adherence. As additional dialysis organizations adopt TIW dosing, including USRC, as John mentioned, we believe we'll continue to see an increase in patient adherence. To continue the success of the Vafseo launch, we need to continue to increase prescribing access across dialysis organizations. With prescribing access for Vafseo at over 260,000 patients today, we expect several dialysis organizations to increase ordering in the fourth quarter of this year and, importantly, to build momentum into 2026.

The increase was primarily driven by higher marketing costs in connection with the Vafseo U.S. This quarter's net income was primarily driven by the increase in net product revenues, which was partially offset by higher operating expenses. In closing, our Q3 financials reflect our continued execution of the Vafseo launch and the continued steadiness of the AURYXIA revenue stream. We look forward to discussing our Vafseo launch progress, as well as the advancement of our pipeline on our next earnings call.

What went well
  • Vafseo generated more total prescriptions through its first 41 weeks than any recent dialysis launch, signaling strong prescriber reception
  • Accessible patients grew from 40,000 at the start of the year to over 260,000 today, including DaVita rolling out broadly to 200,000+ patients
  • Returned to profitability with roughly $540,000 of net income versus a $20 million net loss a year ago
  • AURYXIA delivered a strong quarter at $42.5 million as no generic has yet been approved despite loss of exclusivity in March
  • Win-Odds analysis of INNO2VATE data presented at ASN showed Vafseo patients had lower risk of death or hospitalization versus the ESA control
What went wrong
  • Q3 Vafseo revenue of $14.3 million disappointed management, who stated they were not satisfied with the result
  • Vafseo demand was flat versus Q2 as new patient starts were offset by lower-than-expected initial adherence
  • Adherence at U.S. Renal Care ran below the industry standard and below the anemia managers reverting patients to ESAs instead of titrating Vafseo
  • Getting patients onto therapy took longer than expected due to complex operational and logistical processes at dialysis providers
  • DCI, the fourth-largest dialysis organization, has not yet enabled broad prescribing access through a protocol

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Q&A Summary

What strategies can overcome the Vafseo operational and adherence challenges, and what learnings from the DaVita pilot help?
Adherence problems concentrate at the first refill: patients switched from high-dose ESAs to the 300 mg Vafseo starting dose can see a hemoglobin dip, and anemia managers used to ESAs tend to switch back rather than titrate (study average dose was ~435 mg). Akebia is retraining its sales force and anemia managers on titration and working with dialysis organizations on protocols; recent trends are improving. The DaVita pilot worked out process kinks (clinical review, reimbursement review, specialty pharmacy home fill), and those learnings are being applied to every new organization to improve adherence.
What does the Win-Odds analysis mean for the Vafseo story, and how are clinicians reacting?
It is early (data presented only days earlier at ASN), but meaningful. Overall INNO2VATE showed about 1% lower mortality and 8% lower hospitalization versus ESA, neither statistically significant; the Win-Odds hierarchical method (prioritizing being alive and out of hospital) drilled into what matters to patients and showed favorable results. Clinicians were excited, but the data cannot be used in the field until published, so Akebia is working to publish quickly and will confirm it prospectively in the VOICE trial.
What is the registrational path for the acute kidney injury program, and has the FDA been engaged?
Not yet, it is early. AKB-9090 for AKI is expected to start Phase 1 early next year. CMO/Head of R&D Steve Burke chairs a drug committee and an AKI section within the ASN-sponsored Kidney Health Initiative, in which the FDA participates; management hopes this yields a streamlined path similar to what emerged for IgAN and FSGS via Parasol, though it is a few years out.
What are the greatest hurdles to expanding into large and mid-sized dialysis organizations, and why hasn't the AURYXIA generic entered?
The biggest hurdle is working through the many operational processes at dialysis providers, which is far more complex than a typical drug launch; once access is in place, driving physician demand is the focus, and physicians already want to prescribe. On AURYXIA, expected March generic approvals have not occurred for unknown reasons; Akebia will keep supplying the market and benefiting from the TDAPA phosphate-binder period, but cannot plan long-term since a generic will eventually be approved.
How should new patient starts at DaVita, DCI and others compare to USRC, and what about inventory dynamics?
USRC should not be extrapolated to other providers: USRC was a top-down push (with strong CMO advocacy) that quickly loaded reimbursed patients but also drove the adherence issues. DaVita, IRC, DCI and Fresenius will be more gradual, prescriber-by-prescriber growth. USRC added about $1 million of inventory in Q3; as USRC shifts from 150 mg home tablets to 300 mg in-center TIW dosing and the supply chain shortens, Q4 inventory will likely be lower, and some physicians may wait for the Q1 TIW protocol before starting new patients.
What are the key components of a successful Vafseo launch going forward?
Three things: access (DaVita's pilot is over with broad availability to 200,000 patients, bringing total access to 260,000, though Fresenius work remains); operational execution (becoming the expert on each dialysis organization's unique process so physicians can easily start patients); and adherence (spreading the USRC learnings, which are being shared at the CMO meeting so organizations change protocols to support better adherence).

More on Akebia Therapeutics, Inc.

Reported 2025-11-10 · figures from the Akebia Therapeutics, Inc. Q3 2025 earnings call.

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