Akebia Therapeutics ((AKBA)) has held its Q1 earnings call. Read on for the main highlights of the call.
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Akebia Therapeutics’ latest earnings call balanced optimism around its flagship anemia drug Vafseo with caution over mounting financial headwinds. Management struck a confident tone on commercial traction and pipeline progress, yet acknowledged pressure from generic erosion in legacy product Auryxia, higher costs, and cash burn that together soften the near‑term outlook for investors.
Vafseo Revenue Hits New Quarterly High
Vafseo net product revenue climbed to $15.8 million in the first quarter of 2026, up 32% from $12.0 million a year earlier and marking the product’s strongest quarter to date. The drug’s growing contribution helped partially offset weakness elsewhere, underscoring Vafseo as Akebia’s primary revenue growth engine.
Patient and Prescriber Adoption Accelerates
Vafseo’s patient base expanded sharply, with nearly 7,500 patients on therapy at quarter end, roughly a 60% quarter‑over‑quarter increase. Prescriber engagement rose as about 1,025 clinicians wrote prescriptions in the quarter, up 28% versus the prior period, with around 30% of prescribers coming from dialysis groups beyond the initial USRC footprint.
Observed Dosing Supports Strong Adherence
Management highlighted that roughly two‑thirds of Vafseo patients were on three‑times‑weekly, clinic‑observed dosing by quarter end, a shift seen as key for chronic anemia management. Under these protocols, first‑refill adherence reached about 86%, aligned with the historical 85–90% range and providing confidence that adherence should remain robust as volumes grow.
Real‑World Data Backs Clinical and Economic Value
New post‑hoc analyses from the INNOVATE trial published in JASN suggested Vafseo may carry a lower risk of death or hospitalization compared with ESAs, strengthening its clinical positioning. An economic review indicated 7.7% fewer hospitalizations, 16% fewer hospitalization days, and a 14.8% reduction in annual Medicare‑based hospitalization costs for vadadustat‑treated patients.
Pipeline Milestones Line Up Through 2027
Akebia outlined a busy clinical calendar, with VOCAL topline data from DaVita clinics on three‑times‑weekly dosing expected by year‑end 2026 and VOICE topline results anticipated in early 2027. Beyond Vafseo, praliciguat is advancing through a Phase II study in FSGS, AKB‑097 is slated for a Phase II basket trial in the second half of 2026, and AKB‑9090 recently entered Phase I with initial results targeted for early 2027.
Broadening Commercial Footprint Beyond USRC
The company reported that adoption of Vafseo is spreading across additional dialysis providers, with IRC and DCI moving quickly to observed dosing protocols and showing rapid uptake. DaVita, viewed as the largest opportunity, is currently using once‑daily dosing but is expected to transition to observed dosing in the second half of 2026, representing a significant potential growth lever.
R&D Strategy Centered on Kidney Disease Portfolio
Akebia used its April R&D Day to showcase preclinical and clinical data on praliciguat and AKB‑097, which it said were well received by clinical experts. Management emphasized a kidney‑disease‑focused pipeline aimed at building a multi‑product franchise, positioning R&D investment as a long‑term value driver despite near‑term earnings pressure.
Liquidity Provides Two‑Year Operating Runway
The company ended the quarter with $162.6 million in cash and cash equivalents, down from $184.8 million at year‑end 2025 but still deemed adequate. Executives reiterated that current cash levels, combined with operating cash flows, are expected to fund the existing operating plan for at least the next two years, reducing immediate financing risk.
Top Line Impacted by Auryxia Decline
Total revenue fell to $53.5 million in the first quarter of 2026 from $57.3 million a year earlier, a 6.6% decline despite strong Vafseo growth. The drop was driven by lower sales of Auryxia, highlighting Akebia’s ongoing transition from a mature, generic‑pressured product to a newer therapy portfolio.
Auryxia Faces Intensifying Generic Competition
Auryxia net product revenue slid to $36.2 million from $43.8 million in the prior‑year quarter, a 17.4% decrease tied to lower pricing and heightened generic competition, including an authorized generic and an additional entrant. Management signaled that Auryxia revenue will likely continue to fall in 2026 versus 2025, further increasing reliance on Vafseo and pipeline assets.
Profitability Hit by Loss and Higher Costs
Akebia posted a net loss of $9.1 million in the quarter, reversing from net income of $6.1 million a year earlier as revenue declines intersected with rising expenses. Higher R&D and SG&A spending related to clinical expansion and added headcount weighed on profitability, underscoring the cost of the company’s growth ambitions.
Inventory Charges Drive Higher Cost of Goods
Cost of goods sold climbed to $12.3 million from $7.6 million, an increase of about 61.8% largely attributed to inventory write‑downs related to Auryxia. These charges, including excess and obsolete stock and scrap, reflect the product’s eroding demand profile and contributed meaningfully to the quarter’s margin compression.
Operating Expenses Climb with Pipeline Investment
Research and development expenses rose to $14.8 million from $9.8 million, a roughly 51% increase driven by stepped‑up clinical activity and additional staff. Selling, general, and administrative costs also rose to $30.4 million from $25.7 million, up about 18.3%, as the company invests in its commercial infrastructure to support Vafseo’s expanding footprint.
Cash Burn and Competitive Risks Weigh on Outlook
Cash and cash equivalents declined by $22.2 million quarter‑over‑quarter, reflecting the net loss and higher working capital needs. Management also noted competitive and enrollment challenges in FSGS following sparsentan’s approval and flagged uncertainty around the timing and magnitude of DaVita’s shift to observed dosing, both of which could influence future growth trajectories.
Guidance Emphasizes Execution and Milestone Delivery
Looking ahead, Akebia guided to continued commercial execution for Vafseo, highlighting sustained TDAPA reimbursement through the rest of 2026 and preparation for bundle entry in 2027. The company expects Auryxia revenue to decline this year, but reaffirmed key milestones including VOCAL topline data by late 2026, VOICE and AKB‑9090 data in early 2027, and initial readouts from praliciguat and AKB‑097 programs beginning in 2027, all underpinned by a projected two‑year cash runway.
Akebia’s earnings call paints the picture of a company in transition, with Vafseo’s rapid adoption and a deepening kidney‑focused pipeline offering a compelling growth story. Yet investors must weigh these positives against falling Auryxia revenue, rising costs, and competitive risks, making the coming quarters critical in proving that Vafseo and the broader pipeline can drive sustainable value.