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Jun 30, 2021
Akebia Q2 2021 Earnings Report
Akebia reported an increase in Auryxia net product revenue and progress with vadadustat regulatory submissions.
Key Takeaways
Akebia Therapeutics reported second quarter 2021 financial results, featuring increased Auryxia net product revenue and advancements in vadadustat's regulatory pathway, including FDA acceptance of the NDA filing with a PDUFA target action date of March 29, 2022.
Vadadustat NDA accepted for filing with the FDA.
Vadadustat PDUFA target action date set for March 29, 2022.
Net product revenue for Auryxia increased to $33.0 million, up 7.4% from Q2'FY20.
Company is preparing a Marketing Authorization Application for vadadustat for submission to the European Medicines Agency.
Akebia
Akebia
Akebia Revenue by Segment
Revenue by Segment
Auryxia Net Product Revenue
CapyFin.comLicense, Collaboration & Other Revenue
CapyFin.com Forward Guidance
Akebia believes that its cash resources will be sufficient to fund its current operating plan through at least the next twelve months. Additionally, the Company believes its cash runway would extend beyond the next twelve months assuming timely regulatory approval of vadadustat and the receipt of associated regulatory milestones.
Positive Outlook
- Auryxia's revenue growth is encouraging.
- Auryxia's product profile is favorable.
- Auryxia therapy is critical.
- Focus and execution on marketing, sales, and payor strategies will continue to drive net product revenue growth.
- Cash resources will be sufficient to fund its current operating plan through at least the next twelve months.
Challenges Ahead
- The company remains cautious due to COVID-19.
- Lower collaboration revenue in the 2021 period.
- The timing of regulatory filings and approvals.
- The potential therapeutic benefits, safety profile and effectiveness of our product candidates, including vadadustat.
- The direct or indirect impact of the COVID-19 pandemic on our business, operations, and the markets and communities in which the Company and its partners, collaborators, vendors and customers operate.
Revenue & Expenses
Visualization of income flow from segment revenue to net income