Analyst Summary:
Akebia Therapeutics has reported its Q4 and full-year 2022 financial results, highlighting an almost 25% net product revenue growth for Auryxia over 2021, which exceeded guidance. The company anticipates having a partner in Europe to deliver its Vafseo treatment to patients with chronic kidney disease on dialysis if approved, with the EC Marketing Authorization potentially being approved by the European Commission in May 2023. Akebia is seeking a partner to commercialize vadadustat, with the European Medicines Agency currently reviewing the drug for the treatment of anemia due to CKD in adults. Akebia enters 2023 with a robust operating plan, including funding for several pipeline opportunities. The company believes its existing cash resources and revenues from Auryxia will be sufficient to fund its current operating plan for at least the next twelve months.
Quotes from CEO and CFO:
“We ended our year delivering on our strategic focus, which included a commitment to maximize Auryxia revenue, support vadadustat globally and thoughtfully invest in our pipeline" - John P. Butler, CEO of Akebia.
“Auryxia revenue continues to fund our business, and we entered 2023 with a robust operating plan, including funding for several compelling pipeline opportunities” - David A. Spellman, CFO of Akebia.
Forward Looking Statements:
Akebia Therapeutics has forward-looking statements on the timing for certain regulatory decisions for vadadustat by the FDA and regulatory authorities in the UK. The company also discusses its goals, objectives, and expectations with respect to its operating plan, expenses, cash resources, and sources of funding for its cash runway, including its belief that its existing cash resources and revenues from Auryxia will be sufficient to fund its current operating plan for at least the next twelve months.