Akebia Therapeutics (AKBA) Q2 2024 earnings summary

Executive summary

• Vafseo (vadadustat) received FDA approval in March 2024 for anemia in CKD dialysis patients, with U.S. launch expected January 2025 and strong prescriber interest, especially for home dialysis and high-dose ESA patients.

• Akebia regained full U.S. rights to Vafseo after terminating the CSL Vifor agreement, enhancing operational execution and economics.

• Auryxia remains the primary revenue driver, with net product revenues of $41.2M in Q2 2024, but will lose U.S. exclusivity in March 2025, potentially impacting future sales.

• Net loss narrowed to $8.6M for Q2 2024 from $11.2M in Q2 2023, driven by lower R&D and cost of goods sold.

• Cash and cash equivalents were $39.5M as of June 30, 2024, with management projecting sufficient liquidity for at least two years.

Financial highlights

• Total Q2 2024 revenue was $43.6M, with Auryxia net product revenue at $41.2M, down from $42.2M in Q2 2023.

• Licensing and other revenues were $2.4M in Q2 2024, compared to $14.1M in Q2 2023, which included a one-time $10M Medice payment.

• Cost of goods sold was $17M in Q2 2024, including a recurring $9M non-cash amortization charge.

• R&D expenses dropped to $7.6M in Q2 2024, reflecting completed trials and lower headcount.

• Net loss per share was $(0.04) in Q2 2024, improved from $(0.06) in Q2 2023.

Outlook and guidance

• Vafseo U.S. launch is planned for January 2025, with expected product availability, CMS reimbursement under TDAPA, and no significant expansion of sales force or manufacturing needed for initial demand.

• Auryxia's U.S. revenue is expected to remain stable in 2024 but decline after loss of exclusivity in March 2025.

• Management expects to fund operations for at least 24 months with existing cash and projected revenues.

• Expects to complete all Vafseo supply contracts with dialysis organizations by January 2025.

• Plans to expand Vafseo use post-TDAPA to the entire dialysis market and pursue non-dialysis CKD label expansion.