Those are advancing our kidney disease pipeline and making Vafseo standard of care for the treatment of anemia due to CKD in dialysis patients. I believe our pipeline is underappreciated, and clinical advancement of our rare disease pipeline specifically provides the greatest opportunity to build value. We believe our mid-stage pipeline products, ebribafusp and praliciguat, have the potential to deliver differentiated and targeted approaches to severe diseases with high unmet need. In the meantime, I'm pleased to report that we had our first quarter with over 10,000 patients and $20 million in revenue.

We're pleased to report significant sequential quarterly revenue growth as well as several adoption metrics and an important milestone with more than 10,500 patients active on Vafseo. Vafseo net product revenue increased to $21.3 million in quarter two of 2026, a 34% increase over the previous quarter, representing a continuation of robust growth. The total patients on therapy in quarter two represents an approximate 41% increase compared with quarter one. The mid-sized dialysis organizations, USRC, IRC, and DCI, drove the most significant portion of patient growth.

Driving prescribing within DaVita is our highest priority as it represents our most significant growth opportunity from a single dialysis organization. We believe this bodes well for more impactful growth at the end of the year and sets us up well for 2027. The goal is to increase the efficiency and effectiveness of our commercial field team, while at the same time taking advantage of the broad awareness and breadth of patient access created previously. Turning to the components of total revenues, Vafseo net product revenues were $21.3 million in Q2 2026 compared to $13.3 million in Q2 2025, representing a 60% year-over-year increase.

What went well
  • First quarter with over 10,500 patients on Vafseo and Vafseo net product revenue crossing $20 million ($21.3M, up 34% sequentially, up 60% year-over-year)
  • VOICE trial stopped early after a positive interim analysis: statistically significant reduction in the composite of all-cause mortality and hospitalization (win odds 1.16, p=0.0016), driven by a 10% hospitalization reduction
  • Highest number of new Vafseo patient starts in a quarter since the first quarter of launch, with prescriber base up 17% versus Q1 and about one-third of prescribers now outside USRC
  • Initiated the phase II BASKET trial of ebribafusp (formerly AKB-097/ADX-097) in IgA nephropathy, lupus nephritis, and C3 glomerulopathy
  • Roughly 25% of previously discontinued once-daily patients have restarted Vafseo, and first-refill adherence reached about 89%
What went wrong
  • Swung to a net loss of $8.9 million versus net income of $0.2 million a year ago, on lower revenue and higher expenses
  • Total revenue fell to $49.1 million from $62.5 million a year ago, driven by declining Auryxia sales
  • Auryxia net product revenue dropped to $25.5 million from $47.2 million on generic competition and price pressure, expected to keep declining in 2026
  • Vafseo TDAPA period ends December 31, 2026; management plans to reprice Vafseo down into the ESA range, so 2027 revenue is expected to fall despite higher unit volume
  • A $1.9 million charge was taken for the commercial reorganization; DaVita adoption is not expected to increase meaningfully in Q3

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Q&A Summary

Is near-term Vafseo growth more about new patients getting onto therapy or broadening the in-center dosing protocol across current patients?
Most growth is coming from new patients, new clinics, and new prescribers (prescribers up 17% versus Q1, with adoption spreading beyond the existing physician base). Restarts also help: about 25% of once-daily patients who fell off therapy in 2025 have come back on. Nearly every growth metric is rising quarter over quarter.
Can you characterize persistence rates (e.g., 90/80-day) beyond first-refill adherence, and the main reasons for discontinuation now that three-times-weekly dosing exists?
About 89% of patients who get a Vafseo prescription obtain the first refill, then it tapers toward normal churn in the dialysis population. Discontinuations come from hospitalizations (patients go back to an ESA temporarily), and some patients don't tolerate it (e.g., GI issues). The early first-refill drop was largely from anemia managers uneasy with hemoglobin dips under once-daily dosing; adherence is now where management wants it.
What is the timeline for getting VOICE data in front of medical organizations, and how much could it move new prescriber additions?
The data has not yet been presented or published, but the dialysis community is small and Dr. Block is actively discussing the results with peers. USRC (which ran the study), IRC, and DCI are highly supportive; across those three there are about 66,000 patients (at least 80% on an ESA today) versus just over 10,000 treated, leaving large room to grow. Management also believes the published data will matter for DaVita and Fresenius.
How is praliciguat FSGS enrollment progressing, and how do you see potential combination use given recent developments in the space?
Enrollment is progressing in a competitive space; the team won't commit to a six-month data timeline until confident all 60 patients are enrolled. FSGS is a large (~40,000-patient), heterogeneous market where multiple products can help (Travere just reported early FSGS data). Prali could be used alongside therapies like sparsentan; ebribafusp's targeted complement inhibition could combine with B-cell-directed APRIL/APRIL-BAFF inhibitors without added systemic immunosuppression.
How does praliciguat's mechanism differ from sparsentan, and why might that be a benefit?
Sparsentan blocks the angiotensin and endothelin receptors (endothelin being a vasoconstrictor injurious to podocytes). Praliciguat instead stimulates the soluble guanylate cyclase pathway, increasing cyclic GMP; it is a dilator that also protects podocytes and is anti-inflammatory and anti-fibrotic. They achieve similar effects via different pathways, so there's no reason they shouldn't work well together.
How much Vafseo growth was driven by ex-USRC uptake, have providers changed protocols since VOICE, and is there more color/timing on DaVita?
About one-third of prescribers are now non-USRC, reflecting diversification; IRC and DCI started in early 2026 and together approach USRC's size with strong growth. Since VOICE there's been heavy inter-LDO dialogue; the notable protocol change is DaVita rolling out its three-times-weekly observed dosing protocol village-wide in early June. On DaVita, market research (fielded early June by Serix) shows all-time-high awareness, likelihood to recommend, and preference for Vafseo; conversations have become more operational, but exact timing of an uptake step-up is hard to pinpoint.
Have dialysis providers accelerated protocol decisions since the VOICE results were shared?
The main tangible change is DaVita's village-wide rollout of three-times-weekly/observed dosing in early June, which should help physicians overcome home-compliance concerns. Broader clinical conversations (including detailed operational implementation questions from senior clinical teams) have intensified, which management reads as genuine intent to act, though timing remains uncertain.

More on Akebia Therapeutics, Inc.

Reported 2026-08-05 · figures from the Akebia Therapeutics, Inc. Q2 2026 earnings call.

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