The following is a summary of the Akebia Therapeutics, Inc. (AKBA) Q3 2024 Earnings Call Transcript:

Financial Performance:

• Akebia Therapeutics reported a total revenue of $37.4 million in the third quarter of 2024, compared to $42 million in the corresponding quarter of the previous year.

• The decrease in revenue was primarily attributed to a reduction in volume of AURYXIA net product revenue, which fell from $40.1 million to $35.6 million year-over-year.

• Despite a reduction in revenue, costs of goods sold declined to $14.2 million from $18 million, due primarily to the ability to sell commercially inventory previously written down as excess.

Business Progress:

• Akebia is gearing up for the U.S. market launch of Vafseo, an anemia treatment for chronic kidney disease, with market availability expected in January 2025.

• Significant progress has been made in securing TDAPA reimbursement from CMS and receiving HCPCS codes, setting the stage for efficient Vafseo reimbursement once launched.

• Akebia has secured commercial supply contracts covering approximately 60% of patients on dialysis through contracts with major dialysis organizations and group purchasing organizations.

• The initiation of the Vafseo Outcomes In-Center Experience (VOICE) trial with US Renal Care highlights efforts to generate additional clinical data supporting Vafseo. This study is crucial as it allows three times per week dosing and focuses on key endpoints like mortality and hospitalization.

Opportunities:

• Large-scale market opportunity for Vafseo beyond the dialysis population to include non-dialysis chronic kidney disease patients, representing a multibillion-dollar opportunity. Publishing of the FOCUS clinical data and expected FDA engagements might help expand Vafseo's label to nondialysis usage.

• Strategic contracts and strong commercial arrangements ensure that Vafseo has access to approximately 60% of the dialysis market already, with a targeted 100% coverage in view. This broad market access potentially enhances rapid market penetration post-launch.

Risks:

• Explicit risks were not detailed in the earnings call. Based on context from industry norms, potential risks for Akebia could relate to regulatory approvals, market acceptance of Vafseo, and competitive pressures from other treatments in the anemia and kidney care markets.

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