Akebia Q1 2024 Earnings Report
Key Takeaways
Akebia Therapeutics reported total revenues of $32.6 million for Q1 2024, with net product revenues of $31.0 million from Auryxia. The company's net loss was $18.0 million. They are preparing for the launch of Vafseo in January 2025.
Vafseo (vadadustat) tablets FDA approved on March 27, 2024, with launch activities underway and availability expected in January 2025.
Auryxia (ferric citrate) net product revenues were $31.0 million for the first quarter 2024, and Akebia expects 2024 Auryxia net product revenue growth versus 2023.
Akebia plans to submit its application for Transitional Drug Add-on Payment Adjustment (TDAPA) for Vafseo in June and expects TDAPA designation in January 2025.
Akebia signed an amendment to its License Agreement with Vifor International Ltd. to modify the method of repayment of its working capital fund through tiered royalties based upon Akebia’s sales of Vafseo, significantly simplifying the repayment terms.
Akebia
Akebia
Forward Guidance
Akebia expects Auryxia net product revenue growth in 2024 versus 2023 and believes its existing cash resources and cash from operations will be sufficient to fund its current operating plan, including a U.S. Vafseo launch, for at least the next two years.
Positive Outlook
- Auryxia net product revenue growth is expected in 2024 versus 2023.
- Existing cash resources and cash from operations are expected to fund the current operating plan for at least the next two years.
- Cash runway includes the U.S. Vafseo launch.
- Vafseo launch activities are underway.
- Akebia is accelerating contracting discussions with dialysis organizations with a goal to ensure broad access to Auryxia.
Challenges Ahead
- The commercial availability of Vafseo is not expected until January 2025.
- The market potential and acceptance of Vafseo are subject to uncertainty.
- The competitive landscape for Auryxia and Vafseo could impact revenue.
- Decisions made by health authorities, such as the FDA, could affect regulatory filings.
- Manufacturing, supply chain, and quality matters could have potential consequences.