Akebia Therapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights

Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the first quarter ended March 31, 2023 and provided business highlights.

“Approval of Vafseo™ (vadadustat) by the European Commission is a significant milestone for us and for dialysis patients in Europe with anemia due to chronic kidney disease,” said John P. Butler, Chief Executive Officer of Akebia. “This is an important step as we continue to deliver on our commitment to better the lives of people with kidney disease. Now we are working to complete a partnership to launch Vafseo in Europe, and we are eager to conclude our appeal process with the FDA.”

In April, the European Commission granted marketing authorization for Vafseo (vadadustat), for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. Akebia plans to select a partner to commercialize Vafseo in Europe. Vadadustat is now approved in 32 countries. Akebia also expects a regulatory opinion on vadadustat in the United KingdomSwitzerland and Australia over the course of this year.

In the U.S., Akebia has continued to engage with the Office of New Drugs on its Formal Dispute Resolution regarding vadadustat. Dr. Stein, the deciding authority on the appeal, indicated he has completed his internal discussions, and the company expects a response within the next 30 days.

Akebia also recently reported positive top-line results from FO2CUS, a study evaluating the efficacy and safety of vadadustat in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent (ESA) to three times weekly oral vadadustat dosing for the maintenance treatment of anemia. The data demonstrated that vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA in the treatment of anemia due to chronic kidney disease in patients on hemodialysis when used three times a week at the time of dialysis and with a comparable safety profile to the current standard of care.

“Our team has been diligent in efforts to manage spend and sustain a reduction in operating costs,” said David A. Spellman, Chief Financial Officer of Akebia. “Auryxia revenue was impacted by a $5 million reduction in the volume of channel inventory from year end. We believe quarterly fluctuations in our revenue will continue, which do not impact revenue guidance of $175$180 million. Our team is delivering operating expense savings, with an almost 50% reduction versus the first quarter of 2022, and almost 30% reduction from the fourth quarter of 2022. We continue to execute strategic decisions to enable us to operate with cash on hand and Auryxia revenue for at least the next twelve months.”

Financial Results

  • Revenues: Total revenue was $40.1 million in the first quarter of 2023 compared to $61.7 million for the first quarter of 2022.
    • Net product revenue was $34.8 million in the first quarter of 2023 compared to $41.4 million in the first quarter of 2022, a 15.9% decrease; and compared with $49.7 million in the fourth quarter of 2022, a 30.0% decrease. The decrease compared to the first quarter of 2022 was primarily due to a reduction in inventory of Auryxia by certain customers, as well as a decline in volume, partially offset by higher net price per tablet. The decrease compared to the fourth quarter of 2022 is primarily due to the previously discussed year-end inventory build up by a customer at the end of 2022, which has now been reduced significantly.
    • License, collaboration, and other revenue was $5.3 million for the first quarter of 2023 compared to $20.3 million for the first quarter of 2022. The decrease was primarily related to a reduction in revenue from the termination of the U.S. and international collaboration agreements between Akebia and Otsuka in the second quarter of 2022.

  • COGS: Cost of goods sold was $19.5 million for the first quarter of 2023 compared to $31.3 million for the first quarter of 2022. The decrease was primarily due to lower excess and obsolescence reserves associated with Auryxia, lower manufacturing costs associated with the supply of Vafseo to Mitsubishi Tanabe Pharma Corporation for commercial sale in Japan, and lower freight costs as a result of a lower volume of shipments. The company continues to carry a non-cash intangible amortization charge of $9.0 million per quarter through the fourth quarter of 2024.

  • R&D Expenses: Research and development expenses were $19.7 million for the first quarter of 2023 compared to $43.8 million for the first quarter of 2022. The decrease was primarily due to decreased headcount related costs as a result of the April 2022 reduction in force, decreased outsourced contract services, decreased clinical trial costs, and development expenses related to vadadustat.

  • SG&A Expenses: Selling, general and administrative expenses were $25.2 million for the first quarter of 2023 compared to $44.3 million for the first quarter of 2022. The decrease was primarily due to decreased headcount related costs as a result of the 2022 reductions in force and lower marketing expenses following receipt of the complete response letter for vadadustat from the U.S. Food and Drug Administration (FDA).

  • Net Loss: Net loss was $26.2 million for the first quarter of 2023 compared to $62.4 million for the first quarter of 2022. The decrease in net loss was due primarily to lower cost of goods sold and lower operating expenses, partially offset by lower revenues.

  • Cash Position: Cash and cash equivalents as of March 31, 2023 were approximately $57.0 million. Akebia believes that its cash resources will be sufficient to fund its current operating plan for at least the next twelve months. Akebia’s objective is to fund its current operating plan with existing cash resources and cash from operations for at least the next twelve months. Future decisions by the FDA or other regulatory agencies related to the potential regulatory approval of vadadustat, or Akebia’s ability to generate additional value from vadadustat through partnerships or other transactions 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 anticipated loss of exclusivity in March 2025.

About Akebia Therapeutics

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.

About Vadadustat

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is an investigational new drug and is not approved by the U.S. Food and Drug Administration (FDA). On March 29, 2022, the FDA issued a complete response letter to Akebia’s New Drug Application for vadadustat for the treatment of anemia due to chronic kidney disease (CKD). Vadadustat is approved in Europe for the treatment of symptomatic anemia due to CKD in adult patients on chronic maintenance dialysis. In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.