Akebia Therapeutics Balances Vafseo Momentum With Headwinds

Akebia Therapeutics ((AKBA)) has held its Q1 earnings call. Read on for the main highlights of the call.

Akebia Therapeutics’ latest earnings call balanced optimism around its flagship anemia drug Vafseo with caution over near‑term financial strain. Management highlighted accelerating demand, strong early adherence, and an expanding kidney‑disease pipeline, but also underscored pressure from Auryxia generics, a swing to net loss, and lingering uncertainties in large‑dialysis uptake and trial enrollment.

Vafseo Delivers Record Quarterly Revenue Growth

Vafseo net product revenue climbed to $15.8 million in Q1 2026, up 32% from $12.0 million a year earlier and marking the product’s strongest quarter to date. This performance stands out against an otherwise softer top line and positions Vafseo as Akebia’s primary growth engine as legacy revenues decline.

Patient and Prescriber Adoption Accelerates

Vafseo’s patient base expanded rapidly, with nearly 7,500 patients on therapy by quarter end, a roughly 60% increase versus Q4 2025. Prescriber numbers also grew, with about 1,025 clinicians writing prescriptions in Q1, up 28% sequentially, and nearly 30% of these prescribers coming from dialysis providers beyond the initial U.S. Renal Care partner.

Observed Dosing Drives Strong Adherence

By the end of the quarter, about two‑thirds of Vafseo patients were on three‑times‑weekly, in‑center observed dosing, aligning intake with dialysis sessions. Under this protocol, first‑refill adherence reached roughly 86%, in line with historical 85–90% levels, which management expects to maintain as more clinics convert to observed dosing.

Real‑World Data Strengthens Clinical Value Proposition

New post‑hoc analysis from the INNOVATE study, published in JASN, suggested Vafseo may lower the risk of death or hospitalization compared with ESA therapy. An accompanying economic study indicated 7.7% fewer hospital events, a 16% drop in hospitalization days, and a 14.8% reduction in annual hospitalization costs for patients treated with vadadustat in a Medicare‑based model.

Key Clinical Milestones on the Horizon

Management highlighted several upcoming readouts, including VOCAL topline data from DaVita clinics by year‑end 2026 and VOICE results in early 2027, both focused on three‑times‑weekly dosing. Beyond Vafseo, the company is advancing praliciguat in a Phase II FSGS study of up to about 60 patients, planning a Phase II basket trial for AKB‑097 in the second half of 2026, and has initiated Phase I testing of AKB‑9090 with topline data expected in early 2027.

Broadening Commercial Footprint Across Dialysis Networks

Akebia is seeing adoption extend beyond its initial partner, U.S. Renal Care, with IRC and DCI moving to observed dosing and reporting rapid uptake. DaVita, the largest opportunity, is showing growth but remains on once‑daily protocols, and while a shift to observed dosing is anticipated in the second half of 2026, management acknowledged uncertainty regarding the pace and scale of that transition.

R&D Strategy Anchored in Kidney Disease Portfolio

The company used its recent R&D Day to showcase preclinical and clinical data for assets like praliciguat and AKB‑097, drawing favorable feedback from medical experts. Executives framed Akebia as an emerging multi‑product kidney‑disease platform, arguing that this focused pipeline could create long‑term value that extends well beyond Vafseo’s current launch phase.

Liquidity Provides Cushion for Near‑Term Execution

Akebia ended Q1 2026 with $162.6 million in cash and cash equivalents, down from $184.8 million at year‑end 2025 but still viewed as adequate. Management stated that existing cash, coupled with operating cash flows, should fund the current business plan for at least the next two years, giving the company runway to execute on its commercial and clinical objectives.

Top Line Hit by Auryxia‑Driven Revenue Decline

Total revenue fell to $53.5 million in Q1 2026 from $57.3 million in the prior‑year quarter, a 6.6% decline even as Vafseo grew. The drop reflects shrinking contributions from Auryxia, which more than offset Vafseo’s gains and underscores Akebia’s reliance on scaling its newer product to stabilize overall sales.

Auryxia Faces Intensifying Generic Competition

Auryxia net product revenue slid to $36.2 million from $43.8 million a year ago, a roughly 17.4% decline driven by lower pricing and broader generic entry, including an authorized generic and a new competitor. Management expects Auryxia sales to fall further in 2026 versus 2025, reinforcing the need for Vafseo and pipeline assets to carry future growth.

Profitability Impacted by Swing to Net Loss

The company reported a net loss of $9.1 million for Q1 2026, compared with net income of $6.1 million in Q1 2025, reflecting revenue pressure and higher costs. This shift back into the red highlights the impact of Auryxia erosion and heavier investment in commercialization and R&D during a critical launch and development phase.

Higher COGS and Inventory Charges Weigh on Margins

Cost of goods sold jumped to $12.3 million from $7.6 million a year ago, an increase of nearly 62% largely tied to Auryxia inventory write‑downs for excess, obsolescence, and scrap. These charges compressed gross margins and illustrate the financial drag created by managing a declining product in a rapidly commoditizing market.

Rising Operating Expenses Reflect Investment Cycle

R&D spending rose to $14.8 million from $9.8 million, up about 51%, driven by expanded clinical trial activity and added headcount to support the pipeline. SG&A expenses also increased to $30.4 million from $25.7 million, roughly 18.3% higher, as Akebia invests in commercial infrastructure and personnel to grow Vafseo’s presence across dialysis providers.

Cash Burn Highlights Execution Risk

Cash and equivalents fell by $22.2 million quarter‑over‑quarter, a roughly 12% decline, reflecting the net loss and higher working capital needs. While the cash runway is described as sufficient, investors will likely watch the pace of spending and revenue ramp closely, given the company’s dependence on Vafseo adoption and pipeline progress.

Competitive and Enrollment Challenges in FSGS

In FSGS, the approval of sparsentan has intensified competition for patients, complicating enrollment for praliciguat’s Phase II study and any future Phase III decision. Management acknowledged that multiple sponsors targeting the same population could slow trial timelines, adding another layer of risk around a key non‑Vafseo growth driver.

Uncertain Timing of DaVita Opportunity

DaVita remains the single largest commercial opportunity for Vafseo, but its slower move to observed dosing introduces variability into Akebia’s growth curve. While company leaders expect DaVita to adopt three‑times‑weekly protocols in the second half of 2026, they cautioned that both the exact timing and the slope of uptake are difficult to predict.

Guidance and Forward‑Looking Outlook

Looking ahead, Akebia guided to continued Vafseo growth within the current reimbursement window and is preparing for bundle entry in 2027 while leveraging TDAPA for the rest of 2026. Management reiterated expectations for declining Auryxia revenues, a cash runway of at least two years, and a busy milestone calendar, including VOCAL by late 2026, VOICE and AKB‑9090 data in early 2027, and initial AKB‑097 and praliciguat readouts from 2027 onward.

Akebia’s earnings call painted a story of a company in transition, with Vafseo’s momentum and an advancing kidney‑focused pipeline offsetting the erosion of its older asset and rising costs. Investors will be watching whether the company can convert strong early adoption, real‑world data, and upcoming trial readouts into sustainable growth before financial headwinds and competitive pressures intensify further.