Akebia Therapeutics reported third‑quarter 2025 results that surpassed consensus expectations, delivering a net product revenue of $58.8 million and an earnings per share of $0.00 versus a consensus estimate of –$0.04. The company’s revenue beat the most widely cited estimate of $52.06 million by $6.7 million, a 12.8% lift that reflects a 10.5% increase in Vafseo sales to $14.3 million and a 3.2% rise in Auryxia revenue to $35.6 million. The earnings beat is attributable to disciplined cost management: selling, general and administrative expenses rose by 8.3% to $12.1 million, largely driven by marketing and headcount investments for Vafseo, but the company offset this with a 4.2% decline in cost of goods sold to $27.5 million, helped by the sale of previously written‑down inventory.
The quarter’s net income of $0.00 represents a turnaround from the $20.0 million net loss reported in Q3 2024 and the $0.2 million net income in Q2 2025. The improvement is driven by the stronger Vafseo performance, which now accounts for 24% of total revenue, and by the company’s ability to keep operating leverage in check despite higher SG&A. Management noted that the Vafseo launch has accelerated market penetration, with nephrologists increasingly adopting the oral ESA as a preferred option for dialysis patients.
A key regulatory update was the Type C meeting with the FDA, which did not align on a Phase III VALOR trial for non‑dialysis patients. Akebia confirmed it will not pursue that study, a decision that limits the company’s ability to expand Vafseo’s label beyond the dialysis market but allows it to focus resources on the current patient population. The company also reported that its operational pilot with DaVita is expected to complete in November 2025, with patient access projected to reach 275,000 by year‑end 2025 and 280,000 in 2026. These milestones are expected to drive further revenue growth in the coming quarters.
CEO John P. Butler emphasized the company’s strategic focus on establishing Vafseo as the standard of care for dialysis patients. "We are making progress in the dialysis market and are confident that the data we are generating will support broader adoption," Butler said. He also acknowledged the disappointment surrounding the FDA decision, stating that the company remains committed to delivering value to patients and shareholders while prioritizing the most impactful opportunities.
The market reaction to the earnings was muted, with investors weighing the positive financial performance against the regulatory setback. While the company beat both EPS and revenue estimates, the decision to forego the VALOR trial and the higher SG&A costs associated with the Vafseo launch tempered enthusiasm. Nonetheless, the company’s guidance for patient access and its continued focus on the dialysis market suggest a positive trajectory for the next fiscal year.
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