Starting with the Vafseo launch, revenues were nearly $16 million in Q1, representing our highest quarter of Vafseo net product revenue to date and demonstrating the growth we expected over Q4 2025. We believe this growth is being driven by dialysis organizations that have chosen to implement an observed dosing protocol. In April, we hosted an R&D day to review our pipeline with the investor community. Overall, we've had a strong start to the year, and we're making meaningful progress on both the commercial execution of Vafseo and the advancement of a pipeline that we believe can support long-term growth.

Like John, I am encouraged by the growth potential for Vafseo in 2026, which we believe is supported by our first quarter trends. I'll recap the quarterly results first and then explain what I believe is driving growth. Q1 brought a significant increase in the number of prescribers writing and patients on Vafseo. The majority of new patients began in March, so Q1 revenue reflects at most only one month of treatment for these patients.

We are clearly seeing more patient starts at DaVita, though more slowly than at other dialysis organizations that have ramped up, and that remains our largest potential growth opportunity from a single dialysis organization. We're pleased to deliver Vafseo revenue growth this quarter as we continue our pursuit to make Vafseo standard of care for the treatment of anemia in dialysis patients with CKD. This increased generic competition is consistent with our expectations and prior guidance. This increase was primarily due to an increase in inventory write-downs, including as a result of excess and obsolescence and scrap, primarily related to AURYXIA during Q1 2026.

What went well
  • Vafseo net product revenue reached nearly $16 million ($15.8M), its highest quarter to date and up 32% year-over-year
  • Patients on Vafseo grew ~60% quarter-over-quarter to nearly 7,500, with the highest new-patient starts since launch quarter
  • Prescriber count rose ~28% over Q4 2025 to approximately 1,025, with ~30% from dialysis organizations other than USRC
  • First-refill adherence held at ~86% for patients on observed (three-times-weekly) dosing protocols
  • Kidney pipeline advanced on multiple fronts: praliciguat Phase II enrolling in FSGS, AKB-9090 Phase I initiated, and INNO2VATE win-statistics analysis published in JASN
What went wrong
  • Swung to a net loss of $9.1 million versus net income of $6.1 million in Q1 2025
  • Total revenue fell to $53.5 million from $57.3 million a year earlier, driven by lower Auryxia sales
  • Auryxia net product revenue dropped to $36.2 million from $43.8 million on lower price and added generic competition (a second generic entered the market)
  • Cost of goods sold rose to $12.3 million from $7.6 million, largely on Auryxia-related inventory write-downs for excess, obsolescence and scrap
  • Cash and equivalents declined to $162.6 million from $184.8 million at year-end 2025

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Earnings Call Themes & Trends

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Q&A Summary

BTIG: What drove the prominent increase in Vafseo patients in March, did it continue into April, and was a specific dialysis provider responsible?
The ~60% quarter-over-quarter patient increase came across all major dialysis organizations. USRC kept growing as observed dosing rolled out to all its clinics, enabling new adds without the low-adherence issues of daily in-center dosing, plus some restarts of patients who had fallen off. IRC and DCI saw aggressive, accelerated adoption once their protocols were in place, and DaVita also grew but lagged as it remained on daily dosing. Diversification away from USRC is viewed as an important measure of broadening adoption.
BTIG: Is FILSPARI's (sparsentan) recent approval relevant to FSGS enrollment for the praliciguat Phase II?
Management sees the approval as positive for patients and supportive of FDA bringing new FSGS therapies forward. It is a competitive space with multiple products in development, but physicians at a recent investigator meeting were excited about praliciguat's unique mechanism. The CMO added that FILSPARI is unlikely to materially affect enrollment since most patients won't respond to it and it will largely become background therapy alongside ACE inhibitors/ARBs; the bigger challenge is competing with other sponsors for patients.
Jefferies: How should we think about the ~86% first-refill adherence as observed dosing scales more broadly across dialysis organizations?
The sample size is now large enough to be confident the ~86% figure will hold, likely bouncing between roughly 85% and 90%. Protocols differ by organization (starting dose, titration frequency, whether switching from Mircera or EPOGEN), but the number has been consistent for the last couple of quarters and there's no reason it shouldn't apply as other organizations come on.
Jefferies: Should Vafseo growth through the rest of 2026 be more linear or back-half weighted as protocol adoption matures?
Management wouldn't guide that granularly. There is substantial room to grow, with about 66,000 patients across USRC, DCI and IRC alone and strong momentum, plus restarts of patients who previously dropped off. DaVita's pace is harder to handicap because it lets physicians choose (a more traditional adoption curve) rather than a top-down push, and its move to a three-times-weekly protocol plus newly publishable data (the JASN win-odds paper) could change the growth curve. They wouldn't call it strictly linear or a hockey stick.
H.C. Wainwright: For praliciguat in FSGS, what is the most clinically relevant change on the 24-week UPCR primary endpoint?
The CMO wants to see something on par with sparsentan, roughly a 20% improvement in UPCR over what ACE inhibitors/ARBs achieve. The critical metric is the proportion of patients reaching a UPCR below 0.7 g/g, since that is now the approvable endpoint for FSGS, and that will drive the decision on whether to advance to Phase III.
H.C. Wainwright follow-up / CEO context: How does the FSGS opportunity look given the sparsentan approval bar?
Management views the sparsentan approval bar as the target and sees the PARASOL findings as providing helpful FDA clarity on the approval path. Given roughly 60,000 FSGS patients in the U.S., disease heterogeneity, and praliciguat's unique mechanism, they believe there is significant room for new entrants, and hitting that clinical threshold will be critical.

More on Akebia Therapeutics, Inc.

Reported 2026-05-07 · figures from the Akebia Therapeutics, Inc. Q1 2026 earnings call.

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