Akebia Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenues were $36.9 million in Q3 2026, a decrease from $58.8 million in Q3 2025.
• Vafseo net product revenues were $14.8 million in Q3 2026, up from $14.3 million in Q3 2025, but lower than Q2 2026 due to customer inventory reduction.
• Auryxia net product revenues were $20.0 million in Q3 2026, down from $42.5 million in Q3 2025.
• License, collaboration, and other revenues were $2.1 million in Q3 2026, compared to $2.0 million in Q3 2025.
• Cost of goods sold was $6.4 million in Q3 2026, down from $9.4 million in Q3 2025.
• Research and development expenses were $16.2 million in Q3 2026, up from $14.9 million in Q3 2025.
• Selling, general, and administrative expenses were $23.5 million in Q3 2026, down from $29.1 million in Q3 2025.
• The company reported a net loss of $14.4 million in Q3 2026, compared to a net income of $0.5 million in Q3 2025.
• Cash and cash equivalents were approximately $159.3 million as of September 30, 2026, compared to $155.5 million as of June 30, 2026.

Guidance and Future Outlook:

• Akebia expects Auryxia revenues to continue decreasing in 2026 compared to 2025 due to generic competition and pricing pressure.
• The company anticipates Vafseo access will expand beyond TDAPA-only patients to nearly all clinically eligible patients in 2027.
• Initial data from the Phase 2 open-label basket trial of ebribafusp alfa is expected in 2027.
• Management plans to refinance its senior secured term loan facility.
• The company believes its existing cash resources and expected revenues will fund its current operating plan for at least two years.

Business Segments and Product Lines:

• Patients on Vafseo increased to approximately 11,500 at the end of Q3 2026, representing a 140% increase from Q3 2025 and an 8.1% increase from Q2 2026.
• The total number of Vafseo prescribers increased to approximately 1,300, up over 7% versus Q2 2026.
• The VOCAL trial met its primary endpoint, demonstrating non-inferiority to ESA in maintaining hemoglobin for patients with anemia due to CKD receiving in-center hemodialysis.
• The VOICE trial presented at ASN Kidney Week showed statistically significant improved safety outcomes (all-cause mortality and hospitalization) for patients treated with vadadustat versus ESA.
• The first patient was dosed in a Phase 2 open-label basket trial evaluating ebribafusp alfa in multiple rare kidney diseases (C3 glomerulopathy, lupus nephritis, or IgA nephropathy).
• Preclinical research and Phase 2 trial data for praliciguat in focal segmental glomerulosclerosis (FSGS) were presented at ASN Kidney Week.

Market and Competitive Landscape:

• Auryxia revenues are facing pressure from generic competition.
• Vafseo revenues were impacted by customer inventory reduction and market dynamics as Vafseo's TDAPA expiration approaches.
• The investigational three-times-weekly (TIW) dosing regimen of vadadustat has been adopted by most dialysis providers.

Risks and Challenges:

• Vafseo carries a boxed warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
• Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events.
• Vafseo is not indicated for use in patients with anemia due to CKD not on dialysis, where trials observed increased risks of mortality, stroke, MI, and serious acute kidney injury.
• Risks include potential delays or failures in clinical trials, regulatory decisions, generic competition, and the ability to refinance debt.

Management Commentary and Tone:

• CEO John P. Butler stated the strategic priority is making Vafseo the standard of care for anemia in dialysis patients and increasing the number of patients on therapy.
• Management expressed confidence that VOICE trial data has the potential to drive Vafseo to become standard of care.
• Mr. Butler highlighted a disciplined approach to investment and a strong cash position while advancing the rare kidney disease pipeline.
• The tone reflects optimism regarding pipeline advancements and future market access expansion despite current revenue headwinds.

Other Key Points:

• A $1.3 million restructuring charge was included in Q3 2026 operating expenses.
• Akebia will host a conference call on November 5, 2026, at 8:00 a.m. EST to discuss results.
• Vafseo is approved for use in 37 countries.
• The company reported a change in fair value of warrant liability of $431,000 in Q3 2026.