Akebia Therapeutics (NASDAQ:AKBA) executives used the company’s fourth-quarter 2025 earnings call to review the first full year of Vafseo’s U.S. launch, discuss efforts to build clinical and economic evidence for broader adoption, and outline pipeline plans in rare kidney disease. Management reported $227 million in combined 2025 net product revenue from Vafseo (vadadustat) and Auryxia, while emphasizing that dialysis-provider implementation and patient adherence dynamics influenced Vafseo demand trends in the second half of the year.
Vafseo launch: expanding access, improving adherence
CEO John Butler said 2025 began “very fast” for Vafseo before “a number of challenges flattened demand in the second half of the year.” He added that the company believes demand growth is beginning to reaccelerate, citing improving dynamics in late 2025 and early 2026.
Chief Commercial Officer Nick Grund provided fourth-quarter details, stating that approximately 800 prescribers wrote a Vafseo prescription in Q4, with an average of about 10.3 prescriptions per prescriber. He noted 128 of those were new prescribers. Grund also said about 25% of new patients in Q4 came from dialysis organizations other than US Renal Care (USRC), with increased new starts at DaVita and IRC compared with Q3.
Despite that broader mix, Grund said Q4 demand was “slightly down” versus Q3, with $6.2 million in Q4 Vafseo net product revenue on about $11 million in demand. He attributed the demand softness primarily to dialysis organizations transitioning to observed in-center dosing protocols, which delayed starts until protocols were available. He said USRC began transitioning in November in about 25% of clinics and that, by the end of Q1, Akebia expects the “vast majority” of USRC in-center patients to be receiving Vafseo three times weekly during dialysis through an observed dosing protocol.
Grund also highlighted a distribution-related inventory effect. USRC’s move from shipping bottles to patients’ homes to stocking bottles at centers drove a one-time inventory drawdown impact of about $4.8 million in Q4 2025, he said.
On adherence, Grund said the first refill rate improved from roughly 75% among daily dosing patients in the first nine months of 2025 to about 91% in Q4 among a “small subset” of patients on observed dosing. He said early January data showed a roughly 87% first refill rate among a larger subset of observed-dosing patients and indicated continuation of “high 80%-90%” adherence into the second prescription, while noting typical monthly discontinuation in this population due to comorbidities, mortality, and transplants.
Clinical and economic data: publication seen as key to uptake
Akebia continued to emphasize evidence generation as central to its goal of making Vafseo a standard-of-care option in dialysis anemia management. Butler pointed to a post hoc hierarchical composite endpoint analysis from the Phase 3 INNO2VATE dialysis program presented at the American Society of Nephrology meeting in November. According to Butler, that analysis showed patients treated with Vafseo had a lower risk of dying or being hospitalized than patients treated with an ESA comparator.
Butler also previewed a cost comparison being presented at the Annual Dialysis Conference (ADC), based on INNO2VATE data, comparing Vafseo to darbepoetin. He said the analysis showed:
- 7.7% lower annual hospitalization rate
- 16% reduction in hospitalization days
- Approximately 15% lower Medicare hospitalization costs for patients treated with Vafseo versus darbepoetin
Butler said this translated to about $3,700 in savings per patient per year, and nearly $2 billion per year if all eligible patients were treated with Vafseo.
In Q&A, Butler said the company is not providing Vafseo revenue guidance. He suggested investors focus on “demand” rather than inventory swings, describing demand as essentially flat at about $12 million in Q2, $12 million in Q3, and $11 million in Q4, while adding that Akebia is “absolutely” expecting—and already seeing—growth from that level. He also cautioned against expecting a “magical hockey stick,” arguing nephrologists tend to adopt therapies more gradually.
Butler underscored the importance of publication, saying Akebia’s medical affairs organization cannot broadly educate physicians with conference-presented analyses until peer-reviewed reprints are available, and that the company expects publication this year for the ASN-presented analysis.
Dialysis-provider adoption: DaVita, IRC, DCI trends
Management discussed dialysis-provider rollout dynamics as a core determinant of utilization. Grund said IRC utilization and adoption improved after IRC made Vafseo available in late August and implemented an observed dosing protocol late in Q4, and he said Dialysis Clinic, Inc. (DCI) has started putting patients on therapy.
On DaVita, Butler said DaVita made Vafseo available widely in late Q4 but is not distributing reimbursement lists to physicians; instead, individual physicians decide whether to prescribe. Grund said DaVita has started physician education by focusing on its home dialysis population, which management said is more than 30,000 patients. Management also said DaVita is contemplating an observed dosing protocol, which they expect could help address adherence challenges.
During Q&A, executives also said Akebia expanded its medical affairs group to increase education efforts, emphasizing that much of the education—particularly around emerging data—must come through medical channels rather than sales.
Pipeline and upcoming milestones
Beyond Vafseo and Auryxia, Butler highlighted a rare kidney disease pipeline initiative, calling it a natural extension of Akebia’s kidney disease focus. The company plans to host an investor R&D Day on April 2 to discuss mid-stage assets praliciguat and AKB-097 and introduce early-stage HIF-PHI candidate AKB-9090.
Butler said praliciguat, an oral once-daily soluble guanylate cyclase stimulator, is being evaluated in a Phase 2 focal segmental glomerulosclerosis (FSGS) trial, with up to about 60 patients. The primary endpoint is change from baseline in urine protein-to-creatinine ratio (UPCR) at 24 weeks.
For AKB-097, a tissue-targeted complement inhibitor acquired in 2025, Butler said Akebia plans to initiate a Phase 2 open-label basket trial in the second half of 2026 in IgA nephropathy, lupus nephritis, and C3 glomerulopathy, assessing safety, PK/PD, and disease-relevant biomarkers such as proteinuria and kidney function. Management said initial data are expected to begin in 2027. In Q&A, the company said it was reworking the protocol to make it less operationally complex and does not plan to activate the IND until the updated protocol is resubmitted.
For AKB-9090, Butler said Akebia plans to initiate a Phase 1 study in healthy volunteers in the first half of 2026, with top-line results later this year, targeting acute kidney injury associated with cardiac surgery. Chief Medical Officer Steven Burke said AKB-9090 has different pharmacokinetics and more widespread tissue penetration than vadadustat, including into the lung and kidney, and performed best in the company’s non-clinical ischemia-reperfusion injury models.
Akebia also highlighted two Vafseo post-marketing studies: the VOCAL study at DaVita evaluating three-times-weekly dosing, with results expected late 2026, and the VOICE trial at USRC evaluating Vafseo versus standard of care on a hierarchical composite of all-cause mortality and hospitalization, with data expected in early 2027.
Financial results: higher revenue, lower annual loss; Auryxia generic headwind
Chief Financial and Chief Business Officer Erik Ostrowski said total revenue was $57.6 million in Q4 2025, up from $46.5 million in Q4 2024, and $236.2 million for 2025, up from $160.2 million in 2024, driven by Vafseo and higher Auryxia sales. Vafseo net product revenue was $6.2 million in Q4 and $45.8 million for the year. Auryxia net product revenue was $48.1 million in Q4, up from $44.4 million, and $181.5 million for 2025, up from $152.2 million in 2024.
Ostrowski said Akebia anticipates generic competition for Auryxia expanding beyond current authorized generic competition and therefore expects Auryxia revenue to decrease in 2026 compared with 2025.
Net loss improved to $12.2 million in Q4 2025 from $22.8 million a year earlier, and to $5.3 million for 2025 from $69.4 million in 2024, which Ostrowski attributed to higher net product revenue partially offset by higher expenses. Cash and cash equivalents were $184.8 million as of Dec. 31, 2025, compared with $51.9 million a year earlier. Ostrowski said Akebia believes existing cash resources and cash from operations will fund its current operating plan for at least the next 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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