Akebia Therapeutics (AKBA) Q2 2024 earnings summary

Executive summary

• Vafseo (vadadustat) received FDA approval in March 2024 for anemia due to CKD in adults on dialysis, with U.S. launch expected January 2025 and full U.S. rights regained after CSL Vifor agreement termination.

• Auryxia remains the primary revenue driver, with net product revenue 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.

• New CFO/Chief Business Officer appointed, bringing significant biotech and finance experience.

Financial highlights

• Total Q2 2024 revenue was $43.6M, down from $56.4M in Q2 2023, mainly due to a prior $10M one-time Medice payment.

• Net product revenue was $41.2M in Q2 2024, down from $42.2M in Q2 2023.

• License, collaboration, and other revenue was $2.4M in Q2 2024, compared to $14.1M in Q2 2023.

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

• R&D expenses dropped to $7.6M in Q2 2024 from $20.2M year-over-year due to completed trials and lower headcount.

Outlook and guidance

• Vafseo U.S. launch is planned for January 2025, with expected product availability and CMS reimbursement under TDAPA.

• Auryxia 2024 net product revenues expected to match 2023 levels, but U.S. revenue is expected to decline after loss of exclusivity in March 2025.

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