Akebia Therapeutics NASDAQ: AKBA executives highlighted a “strong start” to 2026 on the company’s first-quarter earnings call, pointing to record quarterly net product revenue for its anemia drug Vafseo, expanding use of observed dosing protocols at dialysis organizations, and continued progress across a kidney disease-focused development pipeline.
Vafseo launch: revenue record, prescriber growth, and observed dosing momentum
Chief Executive Officer John Butler said the company is focused on three priorities: “drive the near-term launch performance of Vafseo,” continue building evidence to make it a standard of care for dialysis patients, and advance its kidney-focused pipeline. In the first quarter, Butler said Vafseo net product revenue was “nearly $16 million,” which the company described as its highest quarterly Vafseo net product revenue to date.
Chief Commercial Officer Nick Grund attributed growth to broader protocol adoption at dialysis organizations, particularly moves toward observed dosing. “Most dialysis organizations are systematically electing to move to an observed dosing protocol,” Butler said, adding the shift could improve adherence and increase utilization over time.
Grund reported that approximately 1,025 prescribers wrote a Vafseo prescription in the quarter, about 28% more than in the fourth quarter of 2025. He added that approximately 30% of those prescribers were from dialysis organizations other than U.S. Renal Care (USRC). From the patient standpoint, Grund said the number of patients on Vafseo at quarter-end increased about 60% sequentially to “nearly 7,500 patients.” He noted that new patient starts in Q1 were the highest since the initial launch quarter, with most new starts occurring in March, meaning Q1 revenue reflected “at most only one month of treatment for these patients.”
On adherence, Grund said first-refill adherence through the end of March was approximately 86% for patients treated under observed dosing. In response to a question about whether that level should hold as adoption broadens, he said the company has seen the metric “bouncing around between kind of 85 and 90 for the last couple of quarters” and he felt “pretty confident” the 86% level should persist as additional dialysis organizations bring on observed dosing.
Grund also said that by the end of the quarter, observed dosing protocols were available in nearly all USRC clinics, as well as at IRC and DCI. He added that about two-thirds of Vafseo patients were being treated three times weekly by quarter-end, which he expects to rise in coming quarters due to these protocol decisions.
Asked about the sharp increase in March and whether uptake was concentrated in any specific provider, Grund said the growth was broad-based across major dialysis organizations. He said USRC continued to add patients as it expanded observed dosing, and he also pointed to “restarts” at USRC—patients who had previously discontinued daily dosing “perhaps for compliance reasons” and were restarting on therapy under a three-times-weekly observed regimen. He added that IRC and DCI saw “very, very aggressive and accelerated adoption” once their protocols were in place, and that DaVita also posted “significant growth” but remained on a daily dosing protocol and was “lagging a bit behind the others.” Grund said Akebia believes DaVita will implement an observed dosing protocol in the second half of the year.
Butler declined to characterize the cadence of Vafseo growth as linear or back-half weighted, saying the trajectory will be influenced by factors such as the pace of restarts and how quickly DaVita changes its approach. He also said the company expects newly published data to influence adoption, noting that after the publication of a paper in the Journal of the American Society of Nephrology, Akebia’s medical team can now discuss the findings more broadly with physicians.
Clinical evidence: publications, economic analysis, and upcoming VOCAL/VOICE readouts
Butler emphasized ongoing efforts to build clinical evidence for Vafseo, including new publications and presentations from the Phase III INNO2VATE program. He said a post hoc hierarchical composite endpoint analysis was recently published in the Journal of the American Society of Nephrology, and that the analysis “demonstrated that patients treated with Vafseo in the INNO2VATE trial experienced a lower risk of dying or being hospitalized than patients treated with the ESA comparator.”
He also highlighted an economic analysis presented earlier in the quarter at an annual dialysis conference comparing hospitalization costs for vadadustat versus darbepoetin. According to Butler, the analysis showed patients treated with vadadustat had 7.7% fewer hospitalization events annually, a 16% reduction in hospitalization days, and, based on Medicare cost data, a 14.8% lower annual hospitalization cost.
Looking ahead, Butler said top-line results from the VOCAL study—being conducted at DaVita clinics to evaluate three-times-weekly dosing—are expected by year-end. He noted VOCAL includes a sub-study of red blood cell characteristics that the company believes could further differentiate Vafseo versus ESAs. He said top-line data from the VOICE trial, being run by U.S. Renal Care and evaluating Vafseo versus standard of care on a hierarchical composite endpoint of all-cause mortality and hospitalization rates, are expected in early 2027.
Pipeline updates: praliciguat in FSGS, complement program, and AKB-9090 Phase I
Beyond Vafseo, Butler said Akebia’s research and development organization has been “highly productive” in advancing a kidney disease-focused pipeline, which management believes could be an important long-term value driver. He noted the company hosted an R&D day in April featuring external experts and reviewed data supporting praliciguat, a soluble guanylate cyclase stimulator, in focal segmental glomerulosclerosis (FSGS) models and prior clinical data in diabetic kidney disease.
Enrollment in Akebia’s Phase II FSGS study is ongoing, targeting up to about 60 patients on maximally tolerated ACE inhibitor or ARB background therapy. Butler said the study’s primary endpoint is change from baseline in UPCR at 24 weeks.
In the Q&A, Chief Medical Officer Dr. Stephen Burke addressed what the company views as a clinically relevant outcome for UPCR at 24 weeks, saying Akebia would like to see results “on par with what was seen with sparsentan,” or “something around a 20% improvement in the change in UPCR” over what is achievable with ACE inhibitors and ARBs. Burke added that a key metric will be the proportion of patients reaching UPCR below 0.7 grams per gram, which he called “the approvable endpoint now for FSGS,” and said it would drive the decision on whether to proceed to Phase III.
Butler and Burke were also asked whether FILSPARI’s recent approval is relevant to enrollment. Butler said the approval is positive for patients and shows FDA support for new treatments in the population, while Burke said he does not anticipate the approval will have a significant impact on enrollment, describing it as likely to become a background therapy because many patients will not respond.
Butler also discussed AKB-097 (abribafus, or “Ebri”), described as a tissue-targeted anti-C3d complement inhibitor. He said initial data suggest it “quickly leaves the bloodstream” to target tissue sites of complement activation such as the kidney, which the company believes could avoid increased reinfection risk seen with some current complement inhibitors and support lower dosing and a more convenient regimen. Akebia expects to initiate a Phase II open-label basket trial in the second half of the year in IgA nephropathy, lupus nephritis, and C3 glomerulopathy, with initial data expected to begin in 2027 due to the open-label design.
Finally, Butler said the company initiated a Phase I study of AKB-9090, an internally developed HIF-PH inhibitor candidate with an initial focus on preventing acute kidney injury associated with cardiac surgery. The randomized, double-blind, placebo-controlled SAD/MAD study is designed to evaluate safety, tolerability, and pharmacodynamics in up to 70 healthy adult participants, with top-line data expected in early 2027.
Financial results: Auryxia decline offsets Vafseo growth; cash runway of at least two years
Chief Financial and Chief Business Officer Erik Ostrowski reported total revenue of $53.5 million in the first quarter of 2026, down from $57.3 million in the prior-year period. The decrease was driven by lower Auryxia revenue, partially offset by higher Vafseo revenue.
- Vafseo net product revenue: $15.8 million in Q1 2026 versus $12.0 million in Q1 2025 (a 32% increase).
- Auryxia net product revenue: $36.2 million in Q1 2026 versus $43.8 million in Q1 2025, which Ostrowski said was driven by lower Auryxia price.
- License, collaboration, and other revenue: $1.6 million in Q1 2026 versus $1.5 million in Q1 2025.
Ostrowski said an additional generic form of Auryxia has entered the market on top of an authorized generic that has been available for the past year, and that the increased generic competition is consistent with Akebia’s expectations and prior guidance. He reiterated that the company expects Auryxia revenue to decline in 2026 compared with 2025.
On expenses, cost of goods sold rose to $12.3 million from $7.6 million, primarily due to higher inventory write-downs related to excess, obsolescence, and scrap “primarily related to Auryxia.” R&D expense increased to $14.8 million from $9.8 million, driven by higher clinical trial activity for praliciguat and AKB-9090 and higher headcount costs. SG&A expense increased to $30.4 million from $25.7 million, also due to higher headcount-related costs.
Akebia posted a net loss of $9.1 million in Q1 2026 compared with net income of $6.1 million in Q1 2025. Ostrowski attributed the swing to lower Auryxia revenues and higher expenses.
Cash and cash equivalents were $162.6 million as of March 31, 2026, down from $184.8 million at the end of 2025, which Ostrowski said reflected the quarterly net loss and a decrease in working capital. He said the company expects its existing cash resources and cash from operations to be sufficient to fund its operating plan for “at least two years.”
About Akebia Therapeutics NASDAQ: AKBA
Akebia Therapeutics, Inc, a clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts, is focused on the development and commercialization of therapies for patients with kidney disease. The company's lead product candidate, vadadustat, is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to treat anemia associated with chronic kidney disease in both dialysis-dependent and non-dialysis patients. Akebia's research and development efforts also extend to preclinical programs targeting nephrology and related metabolic disorders.
Since its founding in 2007, Akebia has pursued strategic collaborations to advance its clinical pipeline and expand its market reach.
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