Akebia Therapeutics NASDAQ: AKBA reported lower third-quarter revenue and a net loss as sales of its kidney disease drug Auryxia fell and inventory reductions limited revenue growth for its anemia treatment Vafseo, despite a sharp increase in patients receiving the drug.
The company said Thursday that about 11,500 patients were on Vafseo during the quarter, up approximately 140% from a year earlier. Yet Vafseo net product revenue rose just 3% to $14.8 million, as a major customer reduced purchases after finding that patients were receiving lower average doses and attending fewer dialysis sessions than expected.
Chief Executive Officer John Butler said Akebia expects patient growth to continue in the fourth quarter, even as dialysis providers reduce inventory ahead of a change in Vafseo reimbursement and pricing on Jan. 1, 2027.
Inventory Drawdown Masks Patient Growth
Butler said Akebia’s largest customer had assumed an average Vafseo dose of 900 milligrams per dialysis treatment, while actual usage was about 810 milligrams. Patients also attended fewer dialysis sessions than expected, reducing the number of doses administered at clinics using observed dosing.
Based on updated dose and attendance figures, Akebia estimated end-user demand at $19 million to $20 million in the third quarter, up from $17 million to $18 million in the second quarter. Butler said that implied roughly $4 million to $5 million of inventory was removed from the channel during the third quarter.
At midsize dialysis providers USRC, DCI and IRC, Vafseo patients represented about 20% of those treated for anemia, Butler said. He added that 25% of patients who had previously discontinued the therapy had restarted it.
Akebia expects fourth-quarter patient growth to come primarily from those midsize providers. Butler said adoption at the larger dialysis organizations DaVita and Fresenius has been slower than the company wanted.
Pricing and Larger Provider Rollout
Vafseo’s transitional drug add-on payment adjustment, or TDAPA, expires Jan. 1. After that, the treatment will be reimbursed as part of the dialysis bundle rather than billed separately. Butler said access will expand beyond patients eligible for TDAPA reimbursement to nearly all clinically eligible patients.
Akebia expects the average annual cost of Vafseo therapy to be between $1,000 and $1,500 after the transition, reflecting lower prices for competing erythropoiesis-stimulating agents, lower dosing and dialysis attendance. Some post-TDAPA contracts remain under negotiation, Butler said.
Akebia has a 2027 post-TDAPA contract with DaVita and is working on a multiyear extension at DaVita’s request. Butler said he expects DaVita to begin a slow rollout this quarter and a more significant rollout early next year. He said Fresenius is interested in the clinical data but is likely to take longer to move.
Chief Commercial Officer Nicholas Grund said declining prices for competing drugs, including Mircera, were putting pressure on Vafseo pricing. Butler said Akebia’s long-term goal is to make Vafseo a standard of care, potentially treating 200,000 to 250,000 patients and generating peak revenue in the hundreds of millions of dollars.
Trial Results Support Commercial Push
Butler highlighted results from the VOICE trial, which enrolled 2,116 patients and compared Vafseo’s active ingredient, vadadustat, with an ESA. He said the study met its predefined stopping criteria and demonstrated superiority on its primary composite endpoint because of fewer hospitalizations. Hospitalizations were 10% lower among patients treated with vadadustat, with no significant difference in mortality rates, he said.
Akebia also announced positive top-line results from VOCAL, a study conducted at DaVita clinics. Butler said vadadustat administered three times weekly was non-inferior to an ESA in maintaining hemoglobin.
Chief Medical Officer Steven Burke said further VOCAL analyses will examine hemoglobin stability, transfusions and rescue therapies, among other measures. The company has not yet received those data, he said.
Financial Results and Pipeline
Total third-quarter revenue fell to $36.9 million from $58.8 million a year earlier. Auryxia net product revenue declined to $20 million from $42.5 million, and Chief Financial and Chief Business Officer Erik Ostrowski said Akebia continues to expect lower Auryxia revenue in 2026 because of generic competition and pricing pressure.
Akebia posted a net loss of $14.4 million, compared with net income of $500,000 a year earlier. Research and development expenses rose to $16.2 million from $14.9 million, while selling, general and administrative expenses fell to $23.5 million from $29.1 million.
Cash and cash equivalents stood at $159.3 million at quarter-end, including $6.6 million raised through at-the-market equity sales. Ostrowski said existing cash, expected revenue and plans to refinance the company’s senior secured term loan are expected to fund its current operating plan for at least two years.
Akebia is enrolling Phase 2 trials of praliciguat in focal segmental glomerulosclerosis and ebribafusp in several rare kidney diseases. Initial ebribafusp data are expected in 2027; the company did not provide a data timeline for praliciguat.
In closing remarks, Butler said Grund had resigned as chief commercial officer but would remain with Akebia as a consultant while the company works on Vafseo contract extensions and adoption.
About Akebia Therapeutics (NASDAQ:AKBA)
Akebia Therapeutics, Inc is a biopharmaceutical company focused on developing and commercializing therapies for patients with kidney disease and related conditions. The company's primary areas of interest include anemia associated with chronic kidney disease (CKD), iron deficiency, and disorders involving mineral metabolism.
Akebia's key product is Vafseo (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to stimulate the body's natural production of erythropoietin and support red blood cell formation.
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