Akebia Therapeutics Reports 11% Revenue Decline and $69.4 Million Net Loss for 2024

Akebia Therapeutics, Inc. reported net product revenue of $152.2 million for the year ended December 31, 2024, a decrease of 11% compared to $170.3 million in 2023. This decrease was primarily attributed to a reduction in sales volume, partially offset by price increases and the implementation of a new contracting strategy with third-party payors. The company also reported license, collaboration, and other revenue of $8 million in 2024, a significant 67% decrease from $24.3 million in 2023. This decline stemmed from a one-time $10 million upfront payment received in 2023 under the Medice License Agreement, a reduction in revenue from a supply agreement with MTPC, and the absence of a $2.2 million revenue item recognized in 2023. The company incurred a net loss of $69.4 million in 2024, a 34% increase from the $51.9 million net loss in 2023.

Auryxia, Akebia's phosphate binder, will lose exclusivity in March 2025. The company anticipates that its inclusion in the Medicare Part B ESRD bundle may mitigate the impact of this loss of exclusivity, but the ultimate effect on revenue will depend on several factors, including contract maintenance with dialysis organizations and the pricing and market entry of generic competitors. Vafseo, Akebia's HIF-PH inhibitor, received FDA approval in March 2024 for treating anemia in adult dialysis patients and began shipping in January 2025. The company secured commercial supply agreements covering nearly 100% of U.S. dialysis patients and obtained reimbursement under the TDAPA program. International approvals for Vafseo exist in the EU, UK, Switzerland, Australia, South Korea, and Taiwan, with Medice and MTPC responsible for marketing and sales in their respective territories.

Significant changes in operating expenses were also reported. Research and development expenses decreased by 40% to $37.7 million in 2024 compared to $63.1 million in 2023, primarily due to the completion of certain clinical trials and reduced headcount. Selling, general, and administrative expenses increased by 6% to $106.5 million in 2024, mainly due to increased headcount costs and marketing expenses related to Vafseo's launch. The company also reported a $0.5 million loss on the extinguishment of debt related to the repayment of Pharmakon Term Loans. Other expense, net, increased to $18.1 million in 2024 from $5.1 million in 2023, largely due to non-cash interest expense related to the settlement royalty liability from the Vifor Termination Agreement.

Akebia ended 2024 with $51.9 million in cash and cash equivalents and $1.7 million in restricted cash. The company expects its current cash resources and projected revenue from product sales, royalties, and licensing agreements to fund its operating plan for at least 24 months. However, the company may need to raise additional capital through equity or debt financing, or strategic transactions, to support future operations. The company's financial performance is subject to various risks, including competition, regulatory changes, and the success of its commercialization strategies for Auryxia and Vafseo. The company also noted a material weakness in its internal control over financial reporting related to inventory accounting as of December 31, 2024.

As of December 31, 2024, Akebia employed 181 people. The company highlighted its commitment to diversity and inclusion initiatives, including training programs and a focus on building an inclusive workplace. Akebia also detailed its intellectual property portfolio, including patents covering Vafseo and Auryxia, and discussed ongoing opposition proceedings related to Vafseo patents. The company's outlook includes driving Vafseo to become the standard of care for anemia due to CKD, leveraging its HIF-based technology for future pipeline development, and exploring strategic growth opportunities. The company also noted the ongoing legal challenges to the IRA's drug price negotiation program.