Akebia Therapeutics, Inc. (AKBA) SEC Filings & Earnings Calls

Delisting risk if bid price not above $1.00 for 10 consecutive days by April 19, 2027.

“Nasdaq deficiency letter; 180-day cure period; potential delisting if not cured.”

Loss of key commercial leadership could impact revenue growth and market execution.

“Chief Commercial Officer resignation without immediate replacement.”

Auryxia revenue decline due to generic competition and pricing pressure; expected to continue in 2026.

“We continue to expect Auryxia revenues to decrease in 2026 as compared to 2025 due to generic competition and pricing pressure.” · word for word

Vafseo COGS from pre-launch inventory not fully loaded; future margins may be lower as full manufacturing costs are recognized.

“Vafseo-related COGS in both periods was derived from pre-launch inventory, which does not include the full cost of manufacturing.” · word for word

R&D and SG&A expenses increasing; operating losses may persist until Vafseo achieves sufficient scale.

“Research and development expenses were $14.1 million in Q2 2026 compared to $11.0 million in Q2 2025. SG&A expenses were $28.2 million compared to $26.6 million.” · word for word

Generic competition for Auryxia

“On March 11, 2026, Teva Pharmaceuticals Ltd. received approval for its Abbreviated New Drug Application for a generic version of Auryxia, which has subsequently entered the market.” · word for word

Vafseo revenue dependency and royalty burden

“The Company will pay CSL Vifor decreasing quarterly tiered royalty payments ranging from a high single-digit percentage of the Company’s net sales of Vafseo up to $450.0 million to mid-single digit percentage above $450.0 million.” · word for word

Debt refinancing risk

“If the Company is unable to refinance its senior secured term loan, or the Company’s operating performance deteriorates significantly... it would have an adverse effect on the Company’s liquidity and capital resources.” · word for word

No statistically significant difference in mortality rates between Vafseo and ESA; mortality benefit not demonstrated.

“There was no statistically significant difference between mortality rates with Vafseo versus ESA (8.77% versus 8.78% per 100 patient years, incidence rate ratio of 1.00 (95% CI 0.718, 1.391).” · word for word

Dependence on dialysis organizations for patient access; diversification improving but still concentrated.

“Approximately 20% of patients and 30% of prescribers in Q1 2026 were from dialysis organizations other than U.S. Renal Care.” · word for word

Generic competition for Auryxia

“On March 11, 2026, Teva Pharmaceuticals Ltd. received approval for its Abbreviated New Drug Application for a generic version of Auryxia, which has subsequently entered the market.” · word for word

Vafseo revenue dependency and royalty burden

“The Company will pay CSL Vifor decreasing quarterly tiered royalty payments ranging from a high single-digit percentage of the Company’s net sales of Vafseo up to $450.0 million to mid-single digit percentage above $450.0 million.” · word for word

Debt refinancing risk

“If the Company’s operating performance deteriorates significantly from the levels expected in the Company’s operating plan, including if the Company does not achieve its future anticipated Vafseo revenue projections, it would affect the Company’s liquidity and its ability to continue as a going concern in the future.” · word for word

Auryxia loss of exclusivity and generic competition

“In March 2025, Auryxia reached loss of exclusivity. On March 11, 2026, Teva Pharmaceuticals Ltd. received approval for its Abbreviated New Drug Application for Auryxia, which we expect will compete with Auryxia. If additional generics are approved and enter the market, we expect it will adversely impact our revenue.” · word for word

Vafseo commercial execution risk

“Results reflected meaningful over-achievement in Auryxia revenue and results below expectations in Vafseo revenue.” · word for word

Dilution risk from authorized share increase

“The issuance of additional shares of Common Stock may, among other things, have a dilutive effect on earnings per share and on stockholders’ equity and voting rights.” · word for word

Pipeline development risk

“Akebia’s ability to initiate and enroll patients in its clinical trials; decisions made by health authorities, such as the U.S. Food and Drug Administration, with respect to regulatory filings and other interactions.” · word for word

Leadership transition may create uncertainty; no details on replacement or interim plan.

“Departure of a director or principal officer (CEO/CFO change) reported.”

Generic competition for Auryxia

“In March 2025, Auryxia reached loss of exclusivity, or LoE. On January 22, 2026, Teva received tentative approval for its Abbreviated New Drug Application for Auryxia.” · word for word

Dependence on Vafseo commercial success

“Our business is substantially dependent on the commercial success of Auryxia and Vafseo.” · word for word

Need for additional financing

“We may require substantial additional financing to fund our business.” · word for word

Patient demand declined slightly QoQ ($11M vs ~$12M in Q3) due to fewer patient starts as dialysis centers anticipated protocol changes, indicating potential volatility in adoption.

“Patient demand was approximately $11 million. This approximately $1 million decline in demand versus Q3 was driven by fewer patient starts” · word for word

Dependence on Vafseo for near-term revenue; pipeline products are early-stage with no near-term revenue contribution.

“Pipeline advancement continues with enrollment underway for praliciguat Phase 2 clinical trial... AKB-097 Phase 2 rare kidney disease basket trial planned to begin in 2H 2026” · word for word

No material financial risk; lease is standard operating expense.

“Lease terms are typical for office/lab space; no unusual obligations.”

Inventory adjustment at USRC impacted Q4 revenue; adherence protocol changes may cause near-term volatility.

“Within centers that adopted this protocol in Q4, first refill adherence rates improved from 75%... to 91%... This new protocol at USRC contributed to an overall decrease in channel inventory of $4.5-$5 million.” · word for word

Milestone and royalty obligations create future cash outflow risk; clinical and regulatory uncertainties for ADX-097.

“milestone payments upon the achievement of specified development and regulatory milestone events related to the ADX-097 up to an aggregate amount equal to $94.5 million” · word for word

FDA did not align on path for non-dialysis label; VALOR trial not initiated, limiting market expansion.

“Akebia recently completed a Type C meeting with the U.S. Food and Drug Administration (FDA) and did not achieve alignment on Akebia’s proposed path forward for a Phase 3 clinical trial in non-dialysis patients.” · word for word

Auryxia loss of exclusivity

“Auryxia lost exclusivity in the U.S. in March 2025.” · word for word

Dependence on Vafseo commercial success

“Our business is substantially dependent on the commercial success of Auryxia and Vafseo.” · word for word

High debt and royalty obligations

“Long-term debt, net $47,641; Liability related to settlement royalties, net of current portion $52,994; Liability related to sale of future royalties, net of current portion $50,576 as of September 30, 2025.”

Material weakness in internal controls

“We have identified a material weakness in our internal control over financial reporting as of December 31, 2024 relating to our accounting for inventory and inventory related transactions.” · word for word

Generic competition for Auryxia

“The market entry of one or more generic competitors or any third party's attempt to challenge our intellectual property rights will likely limit Auryxia and Vafseo sales and have an adverse impact on our business and results of operation.” · word for word

Regulatory alignment failure with FDA significantly limits Vafseo's commercial opportunity; company now dependent on dialysis-only label.

“does not plan to initiate VALOR and therefore does not expect to pursue a broad label for Vafseo for CKD non-dialysis dependent patients.” · word for word

Clinical trial design disagreement with FDA may indicate broader regulatory challenges for the company's pipeline.

“regulatory alignment for such a trial would require a significantly larger number of patients than proposed, and accordingly would require meaningfully more time and cost to complete.” · word for word