Akebia Q4 2022 Earnings Report
Key Takeaways
Akebia Therapeutics reported total revenue of $55.2 million for the fourth quarter of 2022, compared to $59.6 million for the fourth quarter of 2021. Net loss was $7.6 million for the fourth quarter of 2022, compared to $70.7 million for the fourth quarter of 2021. The company set Auryxia net product revenue guidance at $175-$180M for 2023.
Received positive CHMP opinion for Vafseoâ„¢ (vadadustat); anticipates potential Marketing Authorization in Europe in May 2023
Reported Auryxia® (ferric citrate) net product revenue of $177.1M for 2022, an increase of approximately 24.5% over 2021
Set 2023 Auryxia net product revenue guidance at $175-$180M
Ended the year delivering on strategic focus, including maximizing Auryxia revenue and supporting vadadustat globally.
Akebia
Akebia
Akebia Revenue by Segment
Forward Guidance
Akebia set 2023 net product revenue guidance at $175-180 million. The company believes that its cash resources will be sufficient to fund its current operating plan for at least the next twelve months.
Positive Outlook
- Obtain potential Marketing Authorization for Vafseo expected in Europe in May 2023
- Receive regulatory decision for vadadustat for U.K., Switzerland and Australia
- Receive decision on appeal process related to CRL for vadadustat
- Present data from the IMPACT investigator-sponsored study evaluating the effect of Auryxia as a phosphate binder on utilization of IV iron and erythropoiesis-stimulating agents on dialysis patients
- Present data from the FOCUS study on three times weekly dosing for vadadustat in dialysis patients
Challenges Ahead
- The phosphate binder market continues to contract modestly due to COVID-19 and dialysis staffing issues
- Auryxia revenue guidance for 2023 assumes a reduction in total units sold and inventories returning to normal levels.
- Future decisions by the FDA or other regulatory agencies related to the potential regulatory approval of vadadustat may potentially further extend our cash runway, but are not currently reflected in the operating plan.
- Akebia also plans to continue to work on initiatives to extend its revenues from Auryxia beyond the anticipated loss of exclusivity in March 2025.
- The company remains cautious about a phosphate binder market recovery
Revenue & Expenses
Visualization of income flow from segment revenue to net income