8-K: Akebia Therapeutics Reports Q3 2024 Results and Vafseo Launch Progress

Akebia Therapeutics announced its third quarter 2024 financial results, highlighting progress in the commercial launch of Vafseo and ongoing efforts to expand its market presence.

Summary

• Akebia Therapeutics reported a net loss of $20.0 million for the third quarter of 2024, compared to a net loss of $14.5 million in the same period of 2023.
• Total revenue for the quarter was $37.4 million, down from $42.0 million in the third quarter of 2023, with Auryxia net product revenue decreasing to $35.6 million from $40.1 million.
• The company's cost of goods sold decreased to $14.2 million from $18.0 million year-over-year, benefiting from the sale of previously written-down inventory.
• Research and development expenses decreased to $8.5 million from $13.3 million, while selling, general, and administrative expenses increased to $26.5 million from $22.7 million due to Vafseo launch preparations.
• Akebia has secured commercial supply contracts for Vafseo covering approximately 60% of dialysis patients in the U.S., with market availability expected in January 2025.
• The company expects its current cash resources and cash from operations to fund its operating plan, including the Vafseo launch, for at least two years.
• Akebia initiated the VOICE trial with USRC to evaluate mortality and hospitalization outcomes for dialysis patients taking Vafseo.

Sentiment

Score: 6

Explanation: The sentiment is moderately positive due to the progress in Vafseo's launch and coverage, but tempered by the increased net loss and decreased revenue.

Positives

• Vafseo is progressing towards its U.S. market launch in January 2025.
• Significant progress has been made in securing commercial supply contracts for Vafseo, covering a large portion of the dialysis patient population.
• The granting of TDAPA reimbursement and a Level II Healthcare Common Procedure Coding System code for Vafseo will facilitate its adoption.
• The VOICE trial has been initiated to further demonstrate the clinical benefits of Vafseo.
• Cost of goods sold decreased due to the sale of previously written-down inventory.
• Akebia's cash position is expected to support operations for at least two years.

Negatives

• Akebia experienced a net loss of $20.0 million in Q3 2024, an increase from the $14.5 million loss in Q3 2023.
• Total revenues decreased to $37.4 million in Q3 2024 from $42.0 million in Q3 2023.
• Auryxia net product revenues decreased to $35.6 million in Q3 2024 from $40.1 million in Q3 2023.
• Selling, general, and administrative expenses increased due to Vafseo launch preparations.

Risks

• The commercial success of Vafseo depends on market acceptance, coverage, and reimbursement.
• The company faces competition from other treatments for anemia in dialysis patients.
• There are risks associated with the manufacturing, supply chain, and quality of Vafseo.
• The company's financial performance is subject to various market and economic factors.
• The company's forward looking statements are subject to risks and uncertainties.

Future Outlook

Akebia expects Vafseo to be available in the U.S. market in January 2025 and anticipates its current cash resources and cash from operations will be sufficient to fund its operating plan, including the Vafseo launch, for at least two years. The company also plans to enter into additional contracts with dialysis providers to increase coverage and drive demand for Vafseo.

Management Comments

• Approximately 60 percent of patients on dialysis are now covered under dialysis organization and group purchasing organization contracts for Vafseo, said John P. Butler, Chief Executive Officer of Akebia.
• We expect to enter into contracts with additional dialysis providers to increase coverage over the remainder of 2024 while continuing our efforts to drive demand for Vafseo from prescribers.

Industry Context

This announcement comes as Akebia prepares to launch Vafseo, a new treatment option for anemia in dialysis patients, in a market dominated by existing therapies. The company's focus on securing contracts with major dialysis providers and obtaining reimbursement approvals is crucial for its success. The initiation of the VOICE trial also highlights the company's commitment to demonstrating the clinical benefits of Vafseo.

Comparison to Industry Standards

• Akebia's strategy of securing contracts with major dialysis providers is similar to other pharmaceutical companies launching new drugs in this space, such as those by Amgen and GSK.
• The 60% coverage achieved for Vafseo is a strong start, but the company will need to continue to expand coverage to compete effectively with established treatments.
• The VOICE trial is designed to demonstrate non-inferiority for all-cause mortality and superiority for a 10% reduction in all-cause hospitalization, which are key metrics for evaluating the clinical value of anemia treatments.
• The decrease in Auryxia revenue is a concern, as it is a key revenue driver for the company, and the company will need to manage this decline as Vafseo is launched.

Stakeholder Impact

• Shareholders may be concerned about the increased net loss and decreased revenue, but encouraged by the progress of Vafseo.
• Employees are likely focused on the successful launch of Vafseo.
• Dialysis patients stand to benefit from the availability of a new treatment option for anemia.
• Dialysis providers will need to integrate Vafseo into their treatment protocols.
• Creditors will be monitoring the company's financial performance and cash position.

Next Steps

• Akebia will continue to execute on the commercial launch of Vafseo.
• The company will work to enter into contracts with additional dialysis providers to increase coverage.
• Akebia will continue to drive demand for Vafseo from prescribers.
• The company will continue the VOICE trial with USRC.
• Akebia will monitor the performance of Auryxia and its impact on the bundled payment for dialysis services.

Key Dates

Keywords

Vafseo, vadadustat, Auryxia, dialysis, anemia, chronic kidney disease, TDAPA, commercial launch, clinical trial, reimbursement